Welcome!
Welcome to the course resources for the GCP Update Course. In the lesson linked at the bottom of this page you can find the course video. If you were unable to attend on the day and need a certificate you will be able to download your certificate once you have viewed the video and marked the lesson as complete .
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Course Handout
Useful Links
Eudralex Vol 10 – here you can find all the legislation and guidance for Clinical Trials in the EU
MHRA GCP forum – lots of useful information and examples
MHRA Inspection Metrics 2017-2018
MHRA Inspection Metrics 2018-2019
MHRA Guidance on responding to Inspection findings
MHRA Infringement Notice: Freelance monitor
MHRA Infringement notice: Investigator
MHRA Serious Breaches Guidance
MHRA Guidance on Access to Electronic Health Records
HRA Page on combined approval in the UK
UK SI 2004 1031 – Medicines for Human Use (Clinical Trials) Regulations
UK SI 2006 1928 – Medicines for Human Use (Clinical Trials) Amendment Regulations
Q&A on Reference Safety Information
EMA training on the Clinical Trials Regulation
Transcelerate Risk Based Monitoring Page – lots of information and tools